DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
3. Claims 1-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claims 1-7 and 9 are indefinite in the recitation of “a polypeptide derived from” the specified protein, because neither the nature nor the degree of acceptable derivation is defined.
(ii) Claim 2 is indefinite in the recitation of “a CD3zeta domain,” because it is unknown which CD3zeta domain(s) is/are within the scope of the claim.
(iii) Claim 3 is indefinite as self-contradictory, as it recites an extracellular domain which “comprises,” i.e. contains within itself, a linker and/or a hinge domain which is located “C-terminally of said extracellular domain,” i.e. outside of the extracellular domain.
(iv) Claims 7 and 9 are indefinite in the recitations of N- and C-termini, because the identity of the polypeptide(s) whose termini are being referred to is unknown.
(v) Claim 8 is indefinite in the recitation of “the amino acid sequence KPFWVLVVVGGVLACYSLLVTVAFIIFWV as depicted in SEQ ID NO: 27 or 28,” because neither SEQ ID NO: 27 nor SEQ ID NO: 28 is “KPFWVLVVVGGVLACYSLLVTVAFIIFWV.”
(vi) Likewise, claim 10 is indefinite in the recitation of “the amino acid sequence IFMYLLTVFLITQMIGSALFAVYL as depicted in SEQ ID NO: 29, because SEQ ID NO: 29 is not “IFMYLLTVFLITQMIGSALFAVYL.”
(vii) Likewise, claim 12 is indefinite in the recitation of “the amino acid sequence RSKRSRLLHSDYMNMTPRRPGPTRKHYQPYAPPRDFAAYRS as depicted in SEQ ID NO: 27, 28 or 29, because none of SEQ ID NO: 27, 28 and 29 is “RSKRSRLLHSDYMNMTPRRPGPTRKHYQPYAPPRDFAAYRS.”
(viii) Claim 13 is indefinite as being in improper Markush format. The Office recommends the use of the phrase "selected from the group consisting of ..." with the use of the conjunction "and" rather than "or" in listing the species. See MPEP 803.02.
(ix) Claim 17 is indefinite, because it is subject to alternative interpretations:
(a) a method of preparing a host cell comprising either the nucleic acid molecule of claim 14 or a vector comprising the nucleic acid molecule, and
(b) a method of preparing either a host cell comprising the nucleic acid molecule of claim 14 or a vector comprising the nucleic acid molecule.
(x) Claim 19 is indefinite in the recitation of a method for treating cancer “and” chronic viral infection, because it is limited to treating only those subjects who are afflicted with both cancer and viral infection, which appears inconsistent with the context of the claims.
(xi) Claim 19 is further indefinite in the recitation of the step of administering, because the recipient of the administration is not defined. It is unclear, for example, whether the genus of recipients encompasses in vitro model systems.
(xii) Claims 2-20 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
4. The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
5. Claim 19 is rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contain(s) subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not provide a sufficient enabling description of a method for treating cancer or chronic viral infection comprising administering to the patient the fusion protein of claim 1, or a nucleic acid or vector encoding the protein, or a generically recited “host cell”* comprising the nucleic acid or vector.
(*While the claims may potentially be enabled for treatment methods comprising administering T cells expressing the fusion protein, such methods are not recited in the claims, and the examiner has not made a determination as to whether such language would constitute New Matter.)
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, limited working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to make and use the claimed invention.
Enabling description of a method “treating” of a disease requires that positive clinical outcomes can be achieved with sufficient predictability.
The fusion protein of the invention comprises extracellular, transmembrane, and intracellular domains, i.e. it is not expected to be functionally active unless properly expressed in a cell so that it is incorporated in the cellular membrane in correct orientation.
The specification describes working examples indicating that when expressed on T cells, exemplary fusion proteins within the scope of the claims can activate B cells (trans effect, Fig. 10) and support T cell function (cis-effect, Fig. 11). The specification does not appear to provide specific guidance, direction, or working examples of the effect of the fusion protein expressed in other types of cells.
Based on this, a person of ordinary skill in the art would reasonably conclude that administering the claimed fusion protein, or nucleic acids encoding the fusion protein, or generic “host cells” comprising the nucleic acids is highly unlikely to result in positive therapeutic outcomes. Accordingly, experimentation aimed at practicing the method as claimed would be unnecessarily, and improperly, extensive and undue.
6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claims 1-7 and 18-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Frigault et al (US 20180371068).
Claim interpretation: claim 1 recites an extracellular domain containing “a polypeptide derived from CD40L,” without specifying any limitations on the nature or degree of “derivation,” or any limitations on the size or structure of the resulting “derivative” polypeptide. Therefore, polypeptides of any sequence and any size are within the scope of “extracellular domain,” as presently recited.
Frigault teaches a method comprising transducing a T cell with a chimeric antigen receptor (CAR) comprising, inter alia, an IgG4 hinge domain, a CD28 transmembrane domain, a CD28 costimulatory signaling region, and a CD3 zeta signaling domain (e.g. claim 34), which is within the scope of instant claims 1-7 and 14-17. Frigault further teaches a method of treating cancer comprising administering the T cell to a subject (e.g. claim 38), thereby anticipating claims 18-19. Claim 20 is anticipated, because a kit would be at once envisaged by a person of skilled in the art based on the above teachings.
8. The following post-filing-date references teach fusion proteins which are 95.8% identical to instant SEQ ID NO: 29 (see SCORE): US 20250144213 (SEQ ID NO: 695) and US 20250161358 (SEQ ID NO: 234).
9. The following US Patents share a coinventor and/or an assignee with the present application, and disclose the subject matter of the present claims, but do not contain patented claims which would anticipate or make obvious the presently claimed invention: US 11365237 (cited on IDS) and US 12516101.
10. Conclusion: no claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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